Content about Orphan drugs

December 28, 2012
Watson confirms Velcade patent challenge

Watson Pharmaceuticals on Friday confirmed that Actavis, which was acquired by Watson in October, has filed an abbreviated new drug applications with the Food and Drug Administration seeking approval to market bortezomib, a generic version of Millennium Pharmaceuticals' Velcade.

PARSIPPANY, N.J. — Watson Pharmaceuticals on Friday confirmed that Actavis, which was acquired by Watson in October, has filed an abbreviated new drug applications with the U.S. Food and Drug Administration seeking approval to market bortezomib, a generic version of Millennium Pharmaceuticals' Velcade.

Bortezomib is a proteasome inhibitor for intravenous or subcutaneous administration, approved for treatment of patients with multiple myeloma and patients with mantle cell lymphoma who have received at least one prior therapy.

October 26, 2012
Chemotherapy drug shows "significant" improvement in melanoma patients in late-stage trial

A Swiss subsidiary of drug maker Celgene Corp. said its chemotherapy drug produced "significant" improvement in progression-free survival in patients with a deadly skin cancer that had spread elsewhere in the body.

BOUDRY, Switzerland — A Swiss subsidiary of drug maker Celgene Corp. said its chemotherapy drug produced "significant" improvement in progression-free survival in patients with a deadly skin cancer that had spread elsewhere in the body.

October 26, 2012
FDA approves Teva's Synribo for blood and bone marrow cancer

The Food and Drug Administration has approved what it called the second new drug in two months for a form of leukemia, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved what it called the second new drug in two months for a form of leukemia, the agency said Friday.

The FDA announced the approval of Teva Pharmaceutical Industries' Synribo (omacetaxine mepesuccinate) for chronic myelogenous leukemia, or CML, a disease that the National Institutes of Health expects will be diagnosed in more than 5,400 people this year. The drug is intended for patients whose disease has progressed after treatment with at least two drugs of a class used to treat the disease.

September 5, 2012
FDA approves new drug for rare leukemia

The Food and Drug Administration has approved a new drug for treating a rare blood and marrow cancer that affects older adults, the agency said Tuesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare blood and marrow cancer that affects older adults, the agency said Tuesday.

The FDA announced the approval of Pfizer's Bosulif (bosutinib) for chronic myelogenous leukemia, or CML. According to the FDA, about 5,430 men and women will be diagnosed with CML this year.

The drug is designed for patients with chronic, accelerated or blast-phase Philadelphia chromosome-positive CML, who can't tolerate other therapies or for whom those therapies don't work.

August 6, 2012
FDA approves Sanofi drug for colorectal cancer

The Food and Drug Administration has approved a new drug for treating colorectal cancer that has spread to other parts of the body, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating colorectal cancer that has spread to other parts of the body, the agency said Friday.

April 27, 2012
FDA approves GlaxoSmithKline's Votrient for soft tissue sarcomas

The Food and Drug Administration has approved a drug made by GlaxoSmithKline for certain cancer patients.

PHILADELPHIA — The Food and Drug Administration has approved a drug made by GlaxoSmithKline for certain cancer patients.

January 27, 2012
FDA approves Pfizer's Inlyta for advanced kidney cancer

The Food and Drug Administration has approved a drug made by Pfizer for treating advanced kidney cancer, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Pfizer for treating advanced kidney cancer, the agency said Friday.

The FDA announced the approval of Inlyta (axitinib) for patients with advanced kidney cancer, also known as renal cell carcinoma, who have not responded to another drug for the disease. The drug, a twice-daily pill, works by blocking certain proteins called kinases that are involved with tumor growth and disease progression.

December 20, 2011
Apothecary Shops distributes GlowCap in pilot program

Specialty pharmacy provider The Apothecary Shops is encouraging medication adherence with a cap for pill containers that cues patients with lights and sounds, the company said.

PHOENIX — Specialty pharmacy provider The Apothecary Shops is encouraging medication adherence with a cap for pill containers that cues patients with lights and sounds, the company said.

April 20, 2011
Rituxan OKed as treatment for two inflammatory diseases

The Food and Drug Administration has approved a drug made by Genentech for the treatment of two rare inflammatory disorders, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Genentech for the treatment of two rare inflammatory disorders, the agency said.

March 25, 2011
FDA approves Bristol's cancer drug

The Food and Drug Administration has approved a new treatment for late-stage skin cancer, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for late-stage skin cancer, the agency said Friday.

The FDA approved Bristol-Myers Squibb’s Yervoy (ipilimumab) for patients with melanoma that has spread to other parts of the body, also known as metastasis. More than 68,000 new cases of melanoma were diagnosed in the United States in 2010, and about 8,700 died from it, according to the National Cancer Institute, part of the National Institutes of Health.

February 28, 2011
GSK granted FDA approval for Promacta

The Food and Drug Administration has approved a GlaxoSmithKline drug for a rare blood disorder, GSK said Friday.

PHILADELPHIA — The Food and Drug Administration has approved a GlaxoSmithKline drug for a rare blood disorder, GSK said Friday.

The drug maker announced the approval of Promacta (eltrombopag) for chronic immune thrombocytopenic purpura, or ITP, in patients who have not responded adequately to other therapies. Chronic ITP results in increased destruction of inadequate production of platelets in the blood, creating an increased risk of bruising and bleeding.

The FDA granted Promacta orphan drug designation in May 2008 and accelerated approval in November 2008.

January 19, 2011
Genentech appeals FDA's plan to pull Avastin off market

Drug maker Genentech is hoping to keep a breast cancer treatment on the market as the Food and Drug Administration considers whether to revoke its approval for the disease, according to published reports.

NEW YORK — Drug maker Genentech is hoping to keep a breast cancer treatment on the market as the Food and Drug Administration considers whether to revoke its approval for the disease, according to published reports.

The San Francisco Business Times reported Tuesday that Genentech, part of Swiss drug maker Roche, is appealing the FDA’s plan to revoke approval for the drug Avastin (bevacizumab) as a first-line treatment for advanced HER2-negative breast cancer in combination with paclitaxel chemotherapy.

October 27, 2010
FDA OKs expanded use of Sprycel

The Food and Drug Administration has approved a new usage for a blood cancer drug,...

July 18, 2010
Reporters Notebook

Metabolex has entered an agreement to discover and develop Type 2 diabetes drugs with a...

July 11, 2010
Sprycel receives priority review from FDA

A cancer drug made by Bristol-Myers Squibb and Otsuka Pharmaceutical has received priority review from...

June 22, 2010
Orphan drug designation for Tolera's diabetes drug

The Food and Drug Administration has granted orphan drug designation to an investigational treatment for...

June 17, 2010
Novartis’ Tasigna receives nod from FDA

The Food and Drug Administration has approved a drug as an early treatment for a...

June 13, 2010
Bayer, Onyx: Nexavar fails in lung cancer study

A drug made by Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals failed to extend overall survival...

March 17, 2010
FDA approves Carbaglu

The Food and Drug Administration has approved a drug for treating a condition that causes...

February 18, 2010
Novartis' Tasigna receives priority review from FDA

The Food and Drug Administration will shorten its review time of a Novartis drug under...